Kornimate/medical-research-clean huggingface dataset:
assessment of pain associated with insertion torque and correlation of primary implant stability measurement methods

Conditions: Dental Implantation

Summary: the objective of this observational study is to evaluate the primary stability of dental implants and the relationship between insertion torque and patients' pain levels assessed with the visual analogue scale (vas)

primary implant stability plays a key role in providing osseointegration. higher insertion torque indicates higher primary stability. however, the effect of increased insertion torque on patient pain levels has not been clearly demonstrated. several methods for measuring primary stability have been defined so far. insertion torque, periotest measurements, and resonance frequency analysis are mostly preferred due to their ease of use and non-invasiveness. the aim of the present study is to evaluate the relationship between insertion torque and patients' pain levels assessed with the visual analogue scale (vas) and to assess the relationship between insertion torque, periotest measurements, and resonance frequency analysis.

Eligibility criteria:
inclusion criteria: * no contraindications for implant surgery; * bilateral single-tooth loss in the posterior mandible; * sufficient bone amount for implant diameter and height at the implant site; * at least 3 months after tooth extraction at the implant site; exclusion criteria * history of chronic infection or pain at the implant site; * history of radiotherapy to the head and neck region for any reason; * local or systemic causes of persistent anti-inflammatory or analgesic medication; * patients with suspicion of pregnancy.

Keywords: dental implants dental implantation pain assessment
compassion xt pas - post-approval study of the sapien xt thv in patients with pulmonary valve dysfunction

Conditions: Pulmonary Valve Insufficiency; Pulmonary Valve Stenosis; Heart Defects, Congenital; Congenital Abnormalities; Cardiovascular Diseases; Heart Diseases

Summary: this study will confirm the safety and effectiveness of the edwards lifesciences sapien xt transcatheter heart valve (thv) system in patients with a dysfunctional right ventricular outflow tract (rvot) conduit with a clinical indication for intervention in a post-market setting.

the study is a prospective, non-randomized, multi-center clinical study to assess the safety and effectiveness of pulmonic implantation of the sapien thv in patients with dysfunctional rvot conduits requiring treatment for moderate or severe pulmonary regurgitation (pr) by transthoracic echocardiography (tte) and/or rvot conduit obstruction with a mean gradient of ≥ 35 mmhg by tte.

Eligibility criteria:
inclusion criteria: 1. patient has a dysfunctional, non-compliant rvot conduit. 2. the patient/patient's legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. exclusion criteria: 1. inability to tolerate an anticoagulation/antiplatelet regimen 2. active bacterial endocarditis

Keywords: tetralogy of fallot aortic valve defect/disease resulting in ross procedure transcatheter pulmonary valve implantation transcatheter pulmonary valve replacement pulmonary atresia pulmonary stenosis
efficacy of ketamine in children with severe brain injury for brain cell protection

Conditions: Traumatic Brain Injury

Summary: the purpose of this study is to determine the possible effects of an anesthetic agent called ketamine on the injured brain in children. the researchers think that it will effect the outcomes of children with these injuries.


Eligibility criteria:
inclusion criteria: * are 1 month to 16 years of age; and * are admitted to the picu following severe tbi (any gcs 3-8 inclusive) within 8 hours after the injury; and * are intubated and ventilated for the management of tbi; and * are anticipated to have an indwelling arterial or venous catheter for blood sampling during the first three days of study enrollment; and * have an intra-cranial pressure (icp) monitoring device for management of tbi. exclusion criteria: * are less than 4 kilograms in weight upon admission * are less than 1 month of age; * are greater than 16 years of age; * have a clinical diagnosis of non-accidental tbi; * have suffered immersion injury or prolonged hypoxic injury (lasting greater than 10 minutes); * have a known allergy to ketamine; * have a planned removal of endotracheal tube or the removal of central venous catheter and arterial catheter within 72 hours of study enrollment; * have a current history of neuromuscular disease; * have a current history of hepatic failure; * have a current history of glaucoma * require chronic treatment with anti-epileptic drugs (aeds) or devices; * more than 8 hours have elapsed from the time of injury to picu admission; * have documentation of a positive pregnancy test at the time of enrollment; * if there is a lack of commitment to aggressive intensive care therapies (the subject is either on a dnr status due to pre-existing medical condition, or the family decides to withdraw support prior to participation in the study due to other multiple severe injuries and organ failures resulting from the trauma).

Keywords: traumatic brain injury
automated imaging differentiation of parkinsonism

Conditions: Parkinson Disease; Multiple System Atrophy, Parkinson Variant; Progressive Supranuclear Palsy

Summary: the purpose of this study is to test the performance of the aid-p across 21 sites in the parkinson study group. each site will perform imaging, clinical scales, diagnosis, and will upload the data to the web-based software tool. the clinical diagnosis will be blinded to the diagnostic algorithm and the imaging diagnosis will be compared to the movement disorders trained neurologist diagnosis.


Eligibility criteria:
inclusion criteria: * parkinson's disease diagnosis within 5-9 years of baseline date * msap diagnosis * psp diagnosis exclusion criteria: * metal implants in the body that preclude an mri (pacemaker, metallic clip, neurostimulator, etc) * claustrophobia * pregnancy
a study to evaluate safety and immune response of novartis meningococcal acwy vaccine in healthy adults

Conditions: Meningococcal Meningitis; Meningococcal Infections

Summary: this study will evaluate the safety and immune response of novartis meningococcal acwy conjugate vaccine in healthy adolescents and adults.


Eligibility criteria:
inclusion criteria: * individuals who are 19-65 years of age inclusive and who, after the nature of the study has been explained have provided written informed consent * individuals who are available for all visits and telephone calls scheduled for the study; * individuals who are in good health exclusion criteria: * individuals with a previous or suspected disease caused by n. meningitidis * individuals with previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s) * individuals with previous or suspected disease caused by n. meningitidis * individuals with any serious acute, chronic or progressive disease * individuals who are pregnant or breastfeeding

Keywords: meningococcal meningitis vaccine adolescents adults
concomitant treatment of permanent atrial fibrillation

Conditions: Atrial Fibrillation

Summary: restore-sr study is a multi-center, prospective, nonrandomized study with case matched concurrent controls to evaluate the safety and efficacy of the atricure bipolar system


Eligibility criteria:
inclusion criteria: 1. male or female subject between 18 to 80 years of age 2. subject is scheduled to undergo elective cardiac surgical procedure(s) to be performed on cardiopulmonary bypass including: * coronary artery bypass and/or * mitral valve surgery (repair or replacement) * aortic valve surgery (repair or replacement) * tricuspid valve surgery (repair or replacement) 3. left ventricular ejection fraction ≥ 30% 4. subject is willing and able to provide written informed consent 5. subject has a life expectancy of at least 2 years 6. subject is willing and able to return for scheduled follow-up visits 7. treatment subjects only: subject has a 3 month documented history of continuous atrial fibrillation 8. control subjects only: subject is not in atrial fibrillation at time of surgery exclusion criteria: 1. lone af without indication(s) for concomitant cabg and/or mitral valve surgery, aortic valve surgery, tricuspid valve surgery or double valve surgery 2. prior cardiac surgery (redo -including previous ablation) 3. patient requires atrial septal defect repair or any other concomitant open-heart procedure, other than cabg and/or mitral valve surgery; aortic valve surgery, tricuspid valve surgery or double valve surgery 4. serum creatinine concentration greater than 2.0 mg/dl 5. class iv nyha heart failure symptoms and/or class iv ccs anginal symptoms 6. prior history of cerebrovascular accident within 6 months or at any time if there is residual neurologic deficit 7. active infection 8. known carotid artery stenosis greater than 80% 9. severe peripheral arterial occlusive disease defined as claudication with minimal exertion 10. a known drug and/or alcohol addiction 11. mental impairment or other conditions which may not allow the the subject to understand the nature, significance and scope of the study 12. pregnancy or desire to get pregnant within 12 months of study enrollment 13. requires anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia

Keywords: af atrial fibrillation afib racing heart cabg valve ablation bipolar radiofrequency rf
defining stress resilience and mindfulness effects in rheumatoid arthritis

Conditions: Arthritis, Rheumatoid

Summary: this clinical trial will test a mindfulness program in individuals with rheumatoid arthritis (ra). the main goals of this pilot study are to: * assess patient satisfaction with a mindfulness course * identify barriers to participation in, or completion of, a mindfulness course * gather initial information to understand how a mindfulness course impacts ra symptoms participants will: * complete online questionnaires * attend two in-person study visits, involving a brief joint exam and blood draw * roughly half the participants will have the chance to participate in an 8-week online mindfulness course * roughly half the participants will be invited to participate in an online focus group following completion of the mindfulness course researchers will compare those in the mindfulness course with those receiving standard care in preparation for a larger future study to see how mindfulness impacts stress and inflammation in individuals with ra.

participants will complete an initial eligibility screening, and if they are eligible, they will meet with a study staff member to review study procedures and answer any questions they might have about participating. if they would like to participate following this meeting, they will provide written consent and be enrolled in the study. following enrollment, participants will complete an in-person study visit that will last up to one hour and include a brief joint exam, blood draw, and questionnaires. after this study visit, they will be randomly assigned to "treatment-as-usual" (tau) or the mindfulness group. if assigned to the mindfulness group, they will participate in an 8-week online mindfulness course and online focus group following the course. all participants will complete a final in-person study visit at the end of the study, which will mimic the procedures of the first study visit.

Eligibility criteria:
inclusion criteria: * physician-confirmed diagnosis of rheumatoid arthritis (ra) * access to a web-enabled computer, smartphone, or tablet exclusion criteria: * ra disease activity in remission * current regular mindfulness practice (\> 20 minutes per week) * inability to participate in an intensive 8-week online mindfulness course * prior participation in a mindfulness-based stress reduction (mbsr) course

Keywords: mindfulness rheumatic diseases autoimmune diseases
a study to evaluate tolerability and immunogenicity of v504 administered concomitantly with gardasil (v504-001)(completed)

Conditions: Cervical Cancer; Vulvar Cancer; Vaginal Cancer; Genital Warts; Human Papillomavirus Infection

Summary: the purpose of this study is to evaluate vaccine immunogenicity and how well the body tolerates v504 when given with gardasil.


Eligibility criteria:
inclusion criteria: * females between 16- to 26-years-old * has never had pap testing or has only had normal pap test results. * lifetime history of 0 to 4 sexual partners exclusion criteria: * history of an abnormal cervical biopsy result * history of a positive test for hpv; history of external genital/vaginal warts * currently a user of illegal drugs or an alcohol abuser * history of severe allergic reaction that required medical attention * are pregnant * received a marketed hpv vaccine * currently enrolled in a clinical trial * currently has or has a history of certain medical conditions or is currently taking or has taken certain medications (details will be discussed at the time of consent)
exercise and the receptor for advanced glycation end products (rage)

Conditions: Diabetes Mellitus, Type 2

Summary: this study examines the effects of 12-weeks of aerobic exercise training on the mechanisms driving rage-mediated inflammation in type 2 diabetic humans.

activation of rage (receptor of advanced glycation endproducts (ages)), via binding of ages and other ligands, modulates the development and progression of diabetic complications through persistent and cyclic activation of nuclear factor-kappa beta. targeting rage directly as a therapeutic strategy has largely been unsuccessful. however, rage signaling can be interrupted, in vivo, by adam10 (a disintegrin and metalloproteinase 10) directed proteolytic cleavage of the rage ectodomain, and thus creating a soluble isoform of rage (srage) that is released from the cell and appears into the circulation. maintaining high levels of circulating srage is advantageous as srage will sequester rage ligands and prevent rage cell signaling. although the exact mechanisms of adam10 mediated rage release remain undefined, calcium related and other signaling (sirt1) impact adam10. aerobic exercise presents a unique model for mechanistic study of rage release as muscle contraction induces robust calcium signaling, activates sirt1, and provides stimuli for tissue remodeling and resolution of the metabolic profile that drives inflammation.

Eligibility criteria:
inclusion criteria: * age 40-75 y * type 2 diabetes * overweight or obese (bmi 26-44 kg/m2) * fluency in english (written and verbal) exclusion criteria: * age \ 75 y * bmi \ 44 kg/m2 * existing cardiovascular, cerebrovascular, renal, or hematological disease, or cancer * current use of tobacco * pregnant or lactating * medications that may interfere with study outcomes

Keywords: rage adam10 exercise srage
epstein-barr virus reactivation and the effect of egcg on virus reactivation in remission patients

Conditions: NPC

Summary: the purpose of this study is to investigate the ebv reactivation rate in post-radiation and remission npc patients, evaluate the safety and tolerance of egcg and analyze the observational correlation between ebv reactivation and clinical outcome.

patients with pathologically proven npc, stage ii-ivb and finishing curative rt ≧70 gy within 6 months (± induction/concurrent/adjuvant chemotherapy) will be candidates for this study. before entry, 8 cc venous blood will be obtained for ebv dna and antibody screen tests after patient's consent. those who have undetectable plasma ebv dna (0 copy/ml) and fulfilled with all inclusion and exclusion criteria will be registered. routine re-staging work-ups after rt should show no active lesion in nasopharynx, neck and distant organs. re-staging survey should include nasopharyngoscope, pebv dna assay, cbc, platelet count, renal and liver function tests, cxr, abdominal sonography or ct scan, whole body bone scan, mri or ct scan of the head and neck region. within one week after finishing registration, egcg or placebo should be started. a blood sample before taking egcg/placebo will be collected for antibodies test and pebv dna assay.

Eligibility criteria:
inclusion criteria: * histologically proven npc. * 2010 ajcc stage ii-ivb. * age ≧ 20 years old. * performance status of ecog ≦ 2. * finished rt ≧66 gy within 6 months (± induction/concurrent/adjuvant chemotherapy). * clinical complete remission by re-staging work-ups within 3 months before entry. * plasma ebv dna = 0 copy/ml within 4 weeks before entry. * adequate liver, renal, and bone marrow function:serum total bilirubin level ≦ 2.5 mg/dl. serum creatinine ≦ 1.6 mg/dl. wbc ≧ 3,000/ul. platelet count ≧ 100,000/ul. * no intake of egcg or similar dietary supplements. * signed informed consent. * no further anti-cancer treatment. exclusion criteria: * occurrence of locoregional recurrence or distant metastasis. * inadequate rt or finishing rt \> 6 months. * not complete remission by re-staging work-ups within 3 months before entry. * plasma ebv dna \> 0 copy/ml within 4 weeks before entry. * intake of egcg or similar dietary supplements during recent 3 months. * severe cardiopulmonary diseases (unstable angina and/or congestive heart failure or peripheral vascular disease requiring hospitalization within the last 12 months; chronic obstructive pulmonary disease exacerbation other respiratory illness requiring hospitalization) or clinically significant psychiatric disorders.

Keywords: ebv egcg
prehabilitation and recovery after head and neck cancer surgery

Conditions: Head and Neck Cancer; Head and Neck Neoplasms; Surgery

Summary: implementing a multiphasic, multimodal prehabilitation intervention for people undergoing surgery with free flap reconstruction for the treatment of head and neck cancer.

background: head and neck cancer (hnc) is the 7th most common cancer worldwide, and treatment often involves surgery. hnc surgery is intensive, complications are common, and quality of life (qol) is negatively impacted. support must be expanded to not only help patients survive hnc but to recover faster and live well following surgery. prehabilitation, or optimizing a patient's condition before surgery, is a key opportunity to integrate supportive care early in the clinical care pathway for this underserved patient group. research design and methods: using a mixed-methods approach, the aims of this hybrid implementation-effectiveness study are to (i) implement a multiphasic exercise prehabilitation program for hnc patients in a real-world setting and describe factors influencing implementation across the phases; (ii) determine the safety and tolerability of a multiphasic exercise prehabilitation program for hnc patients; (iii) explore the potential benefits of a multiphasic exercise prehabilitation program for hnc patients, and (iv) build a systematic screening and referral pathway into exercise oncology resources post-operatively. outcomes are detailed below and include patient-reported outcomes, physical function, mobility (step count) and hospital length of stay.

Eligibility criteria:
inclusion criteria: * aged ≥18 years; * histologically verified primary head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, larynx, or in lymph nodes of the neck from an unknown primary tumour * scheduled to undergo oncologic resection or resection for benign disease with free flap reconstruction * approval received from a clinical exercise physiologist (csep-cep) and/or clinician * ability to provide written informed consent and understand study information in english exclusion criteria: * neurological or musculoskeletal co-morbidity inhibiting exercise * diagnosed psychotic, addictive, or major cognitive disorders * severe coronary artery disease (canadian cardiovascular society class iii or greater) * significant congestive heart failure (new york heart association class iii or greater)
adjuvant chemotherapy for high risk uterine leiomyosarcoma

Conditions: Leiomyosarcoma; Uterine Neoplasm

Summary: the purpose of this trial is to study the benefits of giving chemotherapy to women after they have had surgical resection of their primary disease and have no evidence of disease remaining(known as adjuvant therapy). the major objective of this study is to determine the progression free survival. the goal is to prevent relapse or recurrence of their uterine leiomyosarcoma.

patients with a diagnosis of early-stage uterine leiomyosarcoma have a 70% chance of relapse or recurrence of their disease. patients enrolled in this trial will receive 4 cycles of gemcitabine and docetaxel followed by 4 cycles of adriamycin. following completion of chemotherapy, they will be have repeat imaging at regular intervals to monitor for disease recurrence along with periodic clinical evaluations.

Eligibility criteria:
inclusion criteria: * ≥ 18 years of age * high risk uterine lms, figo stage i or ii * pathology review of lms high grade and /or mitotic rate greater than or equal to 5 mitoses/10 hpf * no longer than 12 weeks from surgical resection of cancer * no evidence of residual disease * ecog 0 or 1 * anc ≥ 1,500, hemoglobin ≥ 8.0, platelets ≥100,000 * creatinine ≤ 1.5 x institutional upper limits of normal * adequate liver function * neuropathy (sensory and motor) ≤ ctc grade 1 * negative pregnancy test * signed consent exclusion criteria: * patients with other invasive malignancies * prior therapy with gemcitabine or docetaxel or doxorubicin * hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 * women who are breast feeding * cardiac ejection fraction \<50% * prior pelvic irradiation * treatment with hormone replacement or anti-hormonal agents or other cytotoxic agents

Keywords: early stage high grade uterine leiomyosarcoma adjuvant treatment
cardiac sarcoidosis and fdg-pet

Conditions: Sarcoidosis; Dilated Cardiomyopathy

Summary: sarcoidosis is a multi-systemic inflammatory disorder of unknown cause characterized by the formation of non-caseating granulomas in involved organs. its cardiac involvement may be potentially fatal. although endomyocardial biopsy is required for deﬁnitive diagnosis of cardiac sarcoidosis, it is invasive and lacks sensitivity. the specific diagnostic tool for cardiac sarcoidosis is far from satisfactory. recent studies have revealed that fdg-pet with under fasting conditions is a useful method for identiﬁcation of cardiac sarcoidosis patients. however, to our knowledge, no investigations have been published with regard to fdg quantification for the diagnosis and management of cardiac sarcoidosis by pet.

fasting fdg-pet will be performed in all subjects. serum calcium, c-reactive protein (crp), angiotensin converting enzyme (ace), lysozyme, and b-type natriuretic peptide (bnp) levels will be measured in all patients. all patients will undergo chest x-ray, resting 12-lead ecg, transthoracic echocardiography, and 3 types of radionucleotide imaging using tc-99m sestamibi for myocardial perfusion, ga and fdg for whole-body evaluation. all assessments will be conducted within 2 weeks and no sign indicated any change in disease activity of sarcoidosis. the patients with cardiac involvement will be treated with 30 mg/day of prednisolone orally for the first 4 weeks, then will decrease to a dose of 20 mg/day for the next 4 weeks, and will maintain to a dose of 10 mg/day afterwards.

Eligibility criteria:
inclusion criteria: * subjects between the ages of 35 and 85 years * subjects with systemic sarcoidosis * subjects with idiopathic sarcoidosis exclusion criteria: * subjects with active inflammatory diseases not related to sarcoidosis * subjects with coronary artery disease and primary valvular heart diseases * subjects with uncontrolled diabetes mellitus or insulin treatment * subjects with use of the corticosteroid * subjects with systemic disorders such as active inflammatory, liver, renal, hematopoietic, and malignant disease